FDAs Antimicrobial Drugs Advisory Committee votes 9 to 6 against recommending approval for Bayer HealthCare Pharmaceuticals ciprofloxacin dry powder f...
Pfizer subsidiary Greenstone recalls multiple lots of diphenoxylate hydrochloride and atropine sulfate tablets because the products have the potential...
FDA commissioner Scott Gottlieb says the agency is taking steps to improve certain drug shortages at hospitals caused by hurricanes that devastated Pu...
FDA issues a guidance answering questions about the direct marking of medical devices under the unique device identification regulation.
The Senate approves a House bill retaining FDA authority over battlefield drug and medical device decisions.
FDA approves Genentechs Gazyva (obinutuzumab) in combination with chemotherapy, followed by Gazyva alone in those who responded, for people with previ...
Federal Register notice: FDA announces a 1/10/2018 Bone, Reproductive and Urologic Drugs Advisory Committee meeting that will discuss a Lipocine Inc. ...
Federal Register notice: FDA announces that an initial decision of the administrative law judge (ALJ) is now the final agency decision on refusing app...